Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FD EMS, MODEL # D-FJ30E

K-Number: K063642 · 2007-12-13

ApplicantFuji Dynamics Limited
Decision Date2007-12-13
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FD EMS, MODEL # D-FJ30E is the device name listed in this FDA 510(k) record. The listed applicant is Fuji Dynamics Limited. It received FDA 510(k) clearance on 2007-12-13 under 510(k) number K063642. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FD EMS, MODEL # D-FJ30E?

FD EMS, MODEL # D-FJ30E is a medical device that received FDA 510(k) clearance on 2007-12-13. The listed applicant is Fuji Dynamics Limited. The 510(k) number is K063642.

When did FD EMS, MODEL # D-FJ30E receive FDA 510(k) clearance?

FD EMS, MODEL # D-FJ30E received FDA 510(k) clearance on 2007-12-13, under 510(k) number K063642.

Who is the listed applicant for FD EMS, MODEL # D-FJ30E?

The FDA 510(k) record lists Fuji Dynamics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FD EMS, MODEL # D-FJ30E?

The FDA product code for FD EMS, MODEL # D-FJ30E is IPF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Fuji Dynamics Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K092780INF 4160 PLUS, MODEL D-FJ31FK052813FD TENS 2030, MODEL DFJ24TK043407INF 4160, MODEL D-FJ27FK041164L-TENSK994265MEDISANA DIGITAL TENSK994266FDTENS 2010

View all 7 devices →

Related Devices (Code: IPF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑